Rudolph A, Savage DR
J Pediatr Adolesc Gynecol - (-) - [2023-03-17; online 2023-03-17]
To review and characterise reports of vulval aphthous ulcers (VAU) following COVID-19 vaccination in VigiBase, the World Health Organization global database of reported potential side effects of medicinal products, to demonstrate the importance and power of case reports for rare suspected adverse reactions and to investigate whether they suggest a potential for COVID-19 vaccination to be a trigger. Cases reporting the Medical Dictionary for Regulatory Activities' (MedDRA) Preferred Term (PT) "Vulvovaginal ulceration" and related PTs in adolescent patients aged 12 to 17 years in association with any COVID-19 vaccine were extracted from VigiBase. The cases were clinically reviewed, and causality was assessed by applying the Bradford Hill criteria to the obtained case series. As of June 30th, 2022, there were 444 reports for the selected MedDRA PTs following COVID-19 vaccination in VigiBase. Ninety-four de-duplicated reports concerned adolescent female patients. Thirty-seven cases were clinically consistent with the diagnosis of VAU. Upon causality assessment, the analysed case series fulfilled six of the nine Austen Bradford Hill criteria supporting a potential causal relationship. VAU can be perceived as a traumatic experience, especially in adolescent patients. There is, furthermore, a risk that the ulcers will be misdiagnosed resulting in avoidable investigation and treatment burdens for patients. We communicate our findings to support the small number of published case reports and raise awareness of VAU occurring in a temporal association with COVID-19 vaccination. Furthermore, our analysis supports observations about the value of case reports for the recognition and assessment of rare adverse events.